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NCT03077360 · ClinicalTrials.gov registry record · NA

Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans

A NA study of Obesity and Diabetes Mellitus, Type 2, sponsored by University of Colorado, Denver.

Completed
Registry status
NA
Development phase
62
Enrollment target
1
Study location

NCT03077360: Completed NA study of Obesity and Diabetes Mellitus, Type 2, sponsored by University of Colorado, Denver.

NCT03077360 is a NA study of Obesity and Diabetes Mellitus, Type 2 that has completed, run by University of Colorado, Denver. The registered enrollment target is 62 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03077360, a NA study of Obesity and Diabetes Mellitus, Type 2, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
NA
Development phase
62 participants
Enrollment target
1
Study location

Study Summary

The rationale for the proposed research is that elucidating changes in localized diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal specific localized lipids to target in therapeutics for type 2 diabetes. To attain the overall objective, the investigators propose three specific aims: 1. Identify the influence of sarcolemmal DAG and sphingolipids on cell signaling and insulin sensitivity before and after insulin sensitizing lifestyle interventions. Strong preliminary data shape the hypothesis that sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species will decrease after insulin sensitizing lifestyle interventions, leading to less Protein kinase C (PKC) and Protein phosphatase 2A (PP2A) activation, and enhanced insulin signaling. Skeletal muscle DAG and sphingolipid isomers, species, localization, and de novo synthesis will be measured before and after diet-induced weight loss or exercise training interventions in obese men and women. Insulin sensitivity will be measured using insulin clamps, and muscle lipids using Liquid Chromatography Mass Spectrometry (LC/MS). 2. Determine the impact of mitochondrial/ER (endoplasmic reticulum) DAG and sphingolipids on mitochondrial function and ER stress in vivo, before and after insulin sensitizing lifestyle interventions. The investigators hypothesize, again based on preliminary data, that mitochondrial/ER sphingolipids will decrease, yet DAG will increase after insulin sensitizing lifestyle interventions, and each will associate with increased insulin sensitivity. Changes in sphingolipids will relate to increased mitochondrial function, less ER stress, reactive oxygen species (ROS), and acyl-carnitine formation, while changes in DAG will relate to increased mitochondrial content and dynamics. 3. Identify the effect of exogenous DAG and sphingolipids on mitochondrial function in vitro, before and after insulin sensitizing lifestyle interventions. The working hypothesis is that DAG and

Primary Outcome

Hyperinsulinemic/euglycemic clamp measured as glucose infusion rate in mg/kg/min.

Interventions

  • BEHAVIORAL Lifestyle

Study Locations (1)

Colorado

  • University of Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2017-02-01
Est. Completion 2020-11-19
Phase NA
University of Colorado, Denver

1,283 total trials

What the finished NCT03077360 record still lists

NCT03077360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Lifestyle is the first listed.

NCT03077360 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT03077360 about?

NCT03077360 is a clinical study titled "Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans". The rationale for the proposed research is that elucidating changes in localized diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal specific localized lipids to target in therapeutics for type 2 diabetes. To attain the overall objective, the investigators prop...

What is the current status of trial NCT03077360?

This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2017-02-01. Estimated completion is 2020-11-19.

What conditions does trial NCT03077360 study?

This clinical trial studies the following conditions: Obesity, Diabetes Mellitus, Type 2, PreDiabetes.

What interventions are being tested in trial NCT03077360?

The interventions under investigation include: Lifestyle (BEHAVIORAL).

Who is sponsoring clinical trial NCT03077360?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03077360 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03077360's enrollment target sits among peer trials

62 632nd of 1053 higher than 418 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03077360, the US trial registry maintained by the National Library of Medicine. NCT03077360 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.